Pharsight

1. List of Cibinqo drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US9545405	PFIZER	Pyrrolo[2,3-D]pyrimidine derivatives	Feb, 2034 (11 years from now)
US9035074	PFIZER	Pyrrolo[2,3-D]pyrimidine derivatives	Feb, 2034 (11 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9549929	PFIZER	Pyrrolo[2,3-D]pyrimidine derivatives	Feb, 2034 (11 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jan 14, 2027

Drugs and Companies using ABROCITINIB ingredient

NCE-1 date: January, 2026

Market Authorisation Date: 14 January, 2022

Treatment: Treatment of adults with refractory, moderate-to-severe atopic dermatitis not adequately controlled with other systemic drug products or when use of those therapies is inadvisable

Dosage: TABLET;ORAL

Strength	Dosage	Availability
50MG	TABLET;ORAL	Prescription
100MG	TABLET;ORAL	Prescription
200MG	TABLET;ORAL	Prescription

2. List of Daurismo drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8148401	PFIZER	Benzimidazole derivatives	Jan, 2031 (8 years from now)
US10414748	PFIZER	Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate	Apr, 2036 (13 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8431597	PFIZER	Benzimidazole derivatives	Jun, 2028 (5 years from now)
US11168066	PFIZER	Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate	Apr, 2036 (13 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Nov 21, 2023
Orphan Drug Exclusivity (ODE)	Nov 21, 2025

Drugs and Companies using GLASDEGIB MALEATE ingredient

NCE-1 date: November, 2022

Market Authorisation Date: 21 November, 2018

Treatment: Use, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (aml) in adult patients who are >= 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy

Dosage: TABLET;ORAL

Strength	Dosage	Availability
EQ 25MG BASE	TABLET;ORAL	Prescription
EQ 100MG BASE	TABLET;ORAL	Prescription

3. List of Ibrance drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US6936612	PFIZER	2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones	Jan, 2023 (11 days ago)
US7208489	PFIZER	2-(pyridin-2-ylamino)-pyrido [2,3-d]pyrimidin-7-ones	Jan, 2023 (11 days ago)
USRE47739	PFIZER	2-(pyridin-2-ylamino)-pyrido[2,3-D]pyrimidin-7-ones	Mar, 2027 (4 years from now)
US10723730	PFIZER	Solid forms of a selective CDK4/6 inhibitor	Feb, 2034 (11 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7456168	PFIZER	2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones	Jan, 2023 (11 days ago)
US11065250	PFIZER	Solid dosage forms of palbociclib	May, 2036 (13 years from now)

Drugs and Companies using PALBOCICLIB ingredient

Market Authorisation Date: 01 November, 2019

Treatment: Palbociclib for hr-pos. her2-neg. advanced or metastatic breast cancer in combo with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or men, or with fulvestrant in pts with disease progression after endocrine therapy

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
75 mg, 100 mg and 125 mg	04 Feb, 2019	12		22 Jan, 2023
75 mg, 100 mg and 125 mg	24 Nov, 2020	1		28 Feb, 2034

Strength	Dosage	Availability
75MG	TABLET;ORAL	Prescription
100MG	TABLET;ORAL	Prescription
125MG	TABLET;ORAL	Prescription

4. List of Lorbrena drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8680111	PFIZER	Macrocyclic derivatives for the treatment of diseases	Mar, 2033 (10 years from now)
US10420749	PFIZER	Crystalline form of lorlatinib free base	Jul, 2036 (13 years from now)
US11299500	PFIZER	Crystalline form of lorlatinib free base hydrate	Oct, 2038 (15 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11020376	PFIZER	Crystalline form of lorlatinib free base	Jul, 2036 (13 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Nov 2, 2023
Orphan Drug Exclusivity (ODE)	Mar 3, 2028
New Indication (I)	Mar 3, 2024

Drugs and Companies using LORLATINIB ingredient

NCE-1 date: November, 2022

Market Authorisation Date: 02 November, 2018

Treatment: Treatment of anaplastic lymphoma kinase (alk)-positive metastatic non-small cell lung cancer, progressed on: crizotinib + at least 1 other alk inhibitor for metastatic disease; Or alectinib, or ceritinib as first alk inhibitor for metastatic disease.; Treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk)-positive as detected by an fda-approved test

Dosage: TABLET;ORAL

Strength	Dosage	Availability
25MG	TABLET;ORAL	Prescription
100MG	TABLET;ORAL	Prescription

5. List of Talzenna drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8420650	PFIZER	Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)	Jul, 2029 (6 years from now)
US8012976	PFIZER	Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)	Oct, 2029 (6 years from now)
US10189837	PFIZER	Crystalline (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt	Oct, 2031 (8 years from now)
US8735392	PFIZER	Crystalline (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt	Oct, 2031 (8 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9820985	PFIZER	Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)	Jul, 2029 (6 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Oct 16, 2023

Drugs and Companies using TALAZOPARIB TOSYLATE ingredient

NCE-1 date: October, 2022

Market Authorisation Date: 16 October, 2018

Treatment: Treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (brca)-mutated (gbrcam) human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
EQ 0.25MG BASE	CAPSULE;ORAL	Prescription
EQ 0.5MG BASE	CAPSULE;ORAL	Prescription
EQ 0.75MG BASE	CAPSULE;ORAL	Prescription
EQ 1MG BASE	CAPSULE;ORAL	Prescription

6. List of Toviaz drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US6858650	PFIZER	Stable salts of novel derivatives of 3,3-diphenylpropylamines	Jul, 2022 (6 months ago)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6858650 (Pediatric)	PFIZER	Stable salts of novel derivatives of 3,3-diphenylpropylamines	Jan, 2023 (24 days ago)
US7807715	PFIZER	Pharmaceutical compositions comprising fesoterodine	Jun, 2027 (4 years from now)
US8501723	PFIZER	Pharmaceutical compositions comprising fesoterodine	Jun, 2027 (4 years from now)
US8088398	PFIZER	Pharmaceutical compositions comprising fesoterodine	Jun, 2027 (4 years from now)
US8088398 (Pediatric)	PFIZER	Pharmaceutical compositions comprising fesoterodine	Dec, 2027 (4 years from now)
US8501723 (Pediatric)	PFIZER	Pharmaceutical compositions comprising fesoterodine	Dec, 2027 (4 years from now)
US7807715 (Pediatric)	PFIZER	Pharmaceutical compositions comprising fesoterodine	Dec, 2027 (4 years from now)

Exclusivity	Exclusivity Expiration
New Indication (I)	Jun 17, 2024
Pediatric Exclusivity (PED)	Dec 17, 2024

Drugs and Companies using FESOTERODINE FUMARATE ingredient

Market Authorisation Date: 31 October, 2008

Treatment: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency

Dosage: TABLET, EXTENDED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
4 mg and 8 mg	31 Oct, 2012	16	10 Dec, 2015	07 Jun, 2027	Eligible

Strength	Dosage	Availability
4MG	TABLET, EXTENDED RELEASE;ORAL	Prescription
8MG	TABLET, EXTENDED RELEASE;ORAL	Prescription

7. List of Troxyca Er drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8685443	PFIZER	Sequestering subunit and related compositions and methods	Jul, 2025 (2 years from now)
US7815934	PFIZER	Sequestering subunit and related compositions and methods	Dec, 2027 (4 years from now)

Drugs and Companies using NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE ingredient

Market Authorisation Date: 19 August, 2016

Treatment: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment by orally administering a plurality of composite subunits as claimed

Dosage: CAPSULE, EXTENDED RELEASE;ORAL

Strength	Dosage	Availability
1.2MG;10MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued
2.4MG;20MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued
3.6MG;30MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued
4.8MG;40MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued
7.2MG;60MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued
9.6MG;80MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued

8. List of Vizimpro drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7772243	PFIZER	4-phenylamino-quinazolin-6-yl-amides	Aug, 2028 (5 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8623883	PFIZER	4-phenylamino-quinazolin-6-yl-amides	May, 2025 (2 years from now)
US10596162	PFIZER	Method for treating gefitinib resistant cancer	Feb, 2026 (3 years from now)
US10603314	PFIZER	Method for treating gefitinib resistant cancer	Feb, 2026 (3 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Sep 27, 2025
New Chemical Entity Exclusivity (NCE)	Sep 27, 2023

Drugs and Companies using DACOMITINIB ingredient

NCE-1 date: September, 2022

Market Authorisation Date: 27 September, 2018

Treatment: First-line treatment of metastatic non small-cell lung cancer (nsclc) with egfr exon 19 deletions or exon 21 (l858r) substitution mutations as detected by an fda-approved test; Administering daily a unit dosage of an irreversible egfr inhibitor covalently binding as claimed for 1st line treatment of gefitinib or erlotinib resistant metastatic nsclc with egfr exon 19 deletion or exon 21 l858r substitution with t790m mutation; Administering daily a unit dosage of an irreversible egfr inhibitor covalently binding as claimed for 1st line treatment of gefitinib of erlotinib resistant metastatic nsclc with egfr exon 19 deletion or exon 21 l858r substitution

Dosage: TABLET;ORAL

Strength	Dosage	Availability
15MG	TABLET;ORAL	Prescription
30MG	TABLET;ORAL	Prescription
45MG	TABLET;ORAL	Prescription

9. List of Xeljanz drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
USRE41783	PFIZER	Pyrrolo[2,3-D]pyrimidine compounds	Dec, 2025 (2 years from now)

Exclusivity	Exclusivity Expiration
New Product (NP)	Sep 25, 2023

Drugs and Companies using TOFACITINIB CITRATE ingredient

Market Authorisation Date: 25 September, 2020

Treatment: NA

Dosage: SOLUTION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg	07 Nov, 2016	3		08 Dec, 2025
10 mg	24 Jul, 2019	1	01 Jun, 2021	08 Dec, 2025	Eligible
1 mg/mL	12 Nov, 2021	1		08 Dec, 2025

Strength	Dosage	Availability
EQ 1MG/ML BASE	SOLUTION;ORAL	Prescription

10. List of Xeljanz Xr drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US6965027	PFIZER	Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile citrate	Mar, 2023 (a month from now)
USRE41783	PFIZER	Pyrrolo[2,3-D]pyrimidine compounds	Dec, 2025 (2 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11253523	PFIZER	Tofacitinib oral sustained release dosage forms	Mar, 2034 (11 years from now)
US10639309	PFIZER	Tofacitinib oral sustained release dosage forms	Mar, 2034 (11 years from now)
US9937181	PFIZER	Tofacitinib oral sustained release dosage forms	Mar, 2034 (11 years from now)

Exclusivity	Exclusivity Expiration
New Indication (I)	Dec 14, 2024

Drugs and Companies using TOFACITINIB CITRATE ingredient

Market Authorisation Date: 23 February, 2016

Treatment: A method of treating ankylosing spondylitis by administering the formulation of tofacitinib of claims 1, 8, 15-20, 27-31, 34-43, 45, 47, 49, 50, 54, 59, 63, 68-71, 73, 77, 82-84, and 87-98; A method of treating psoriatic arthritis by administering the formulation of tofacitinib of claims 1, 8, 15-20, 27-31, 34-44, 46, 48, 50, 53, 59, 62, 68-71, 73, 76, 82-84, and 87-98; A method of treating rheumatoid arthritis by administering the formulation of tofacitinib of claims 1, 2, 8, 9, 15-21, 27-31, 34-43, 50, 51, 59, 60, 68-71, 73, 74, 82-84 and 87-98; A method of treating ulcerative colitis, by administering the formulation of tofacitinib of claims 1, 3, 8, 10, 15-20, 22, 27-31, 34-43, 50, 52, 59, 61, 68-71, 73, 75, 82-84 and 87-98

Dosage: TABLET, EXTENDED RELEASE;ORAL